Kornimate/medical-research-clean huggingface dataset:
intravenous insulin vs subcutaneous insulin infusion in intrapartum management of type 1 diabetes mellitus

Conditions: Type 1 Diabetes; Pregnancy, High Risk

Summary: the purpose of this study is to perform a randomized trial to investigate if intrapartum insulin delivery mechanisms reduces adverse outcomes associated with type 1 diabetes in pregnancy. the investigators aim to compare subcutaneous insulin pump versus intravenous insulin infusion with regard to the primary outcome of neonatal blood sugar.

intrapartum glucose management is critical to reducing neonatal hypoglycemia shortly after birth. some providers are comfortable continuing patients on their subcutaneous insulin pump during labor while others transition these patients to intravenous insulin infusions. previous literature has retrospectively shown this to be both a feasible and safe option. the investigators aim to compare subcutaneous insulin pump versus intravenous insulin infusion with regard to obstetric and neonatal outcomes.

Eligibility criteria:
inclusion criteria: * pregnant women with pre-gestational diagnosis of type 1 diabetes mellitus and managed on an insulin pump in pregnancy * pregnancy and delivery care obtained at university of massachusetts (umass) memorial medical center * patients able to provide written informed consent exclusion criteria: * patients who are under the age of 18 * patients with altered state of consciousness * critically ill patient requiring intensive care unit admission * patient at risk for suicide * patient refuses or is otherwise unable to participate in own care * patient without pump supplies * patients presenting with diabetic ketoacidosis on admission

Keywords: pregnancy type 1 diabetes intrapartum insulin maternal outcomes neonatal outcomes
a study of the pharmacokinetics and pharmacodynamics of intravenously administered pegasys (peginterferon alfa-2a) in patients with chronic hepatitis c and previous non-response to pegylated interferon and ribavirin combination therapy

Conditions: Hepatitis C, Chronic

Summary: in this randomized, cross-over, open label study the correlation of pegasys (peginterferon alfa-2a) pharmacokinetics after intravenous (iv) and subcutaneous (sc) administration with viral load and viral kinetics will be investigated in patients with chronic hepatitis c genotype 1 who were non-responders to previous standard combination therapy with pegylated interferon and ribavirin. patients will be randomized to receive either weekly or twice weekly pegasys iv or sc for 2 weeks, crossing over to the other mode of administration after a washout period of 6 weeks.


Eligibility criteria:
inclusion criteria: * adult caucasian patients, 18 - 70 years of age * hepatitis c, genotype 1 * non-responder to previous anti-hcv therapy with peginterferon alfa and ribavirin * compensated liver disease (child-pugh class a) for \>/= 24 months before baseline * positive for anti-hcv for \> 6 months, with detectable serum hcv-rna exclusion criteria: * treatment-naïve or responder to previous therapy * hcv infection other than genotype 1 * positive for hepatitis a, hepatitis b or hiv infection at screening * chronic hepatitis of other than hcv origin * decompensated liver disease (child-pugh class b or c) * therapy with systemic antiviral, antineoplastic or immunomodulatory agents in the 6 months prior to study * clinically relevant retina disorder * pregnant or lactating women and male partners of pregnant women
reliability and validity of modified postural assessment scale for stroke patients and the application of this scale on early detection of patients with stroke at high risk of falls

Conditions: Stroke

Summary: the purposes of this study are to investigate the reliability and validity of the modified postural assessment scale for stroke patients (mpass) and its applications in early detection of fall-prone patients. the intraclass correlation coefficient will be used to examine the intra-rater reliability, inter-rater reliability, and the cronbach's alpha will be used to examine the internal consistency of the 16 items of mpass.

due to the impaired balance function, patients with stroke show high incidence of falls. impaired postural stability has been shown as one of the primary risk factors of falls in these patients. research has shown that patients who have moderate level of mobility and stability are more likely to fall than those who have very good or very poor mobility and stability. therefore, there is an urgent need for physical therapists, who are used to play an important role in improving balance function of patients with stroke, to be able to early detect stroke patients who are at high risk of falls, and to implement fall prevention training and education on these patients. however, to date, there is not any clinical assessment scale that can be used for early detection of fall-prone stroke patients.

Eligibility criteria:
inclusion criteria: * between 30 and 80 years old * first onset or recurrent stroke as a result of a single cerebral vascular accident (ischemic or hemorrhage stroke) * ever received medical or rehabilitation therapies at national taiwan university hospital * being willing to take the clinical assessments and accept the vedio record exclusion criteria: * having unstable vital sign, unconsciousness, or having serious cognitive, perception, and language impairment, and being unable to follow the order of the experimenter * having other neurological diseases(ex. parkinson's disease or cerebellar disease etc.), or moderate to severe neuromuscular or musculoskeletal disorders, or disorders from systematic diseases those will influence the balance performance other than stroke

Keywords: stroke patients falls reliability validity
study of nivolumab (bms-936558) in patients with advanced or metastatic squamous cell nonsmall-cell lung cancer who have received at least 2 prior systemic regimens

Conditions: Squamous Cell Non-small Cell Lung Cancer

Summary: the purpose of the study is to assess the objective response rate (change in tumor size from baseline) in patients with advanced or metastatic squamous cell nonsmall-cell lung cancer treated with nivolumab (bms-936558) after failure of 2 prior systemic regimens


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * men and women ≥18 years of age * patients with histologically or cytologically documented squamous cell nonsmall-cell lung cancer who present with stage iiib/stage iv disease (according to version 7 of the international association for the study of lung cancer staging manual in thoracic oncology), or with recurrent or progressive disease following multimodal therapy (radiation therapy, surgical resection, or definitive chemoradiation for locally advanced disease * eastern cooperative oncology group performance status of 0 or 1 * disease progression or recurrence after both a platinum doublet-based chemotherapy regimen and at least 1 additional systemic therapy * measurable disease by computed tomography scan/magnetic resonance imaging as per response evaluation criteria in solid tumors, volume 1.1 exclusion criteria: * untreated central nervous system (cns) metastases. metastases have been treated and patients neurologically returned to baseline (except for residual signs or symptoms related to the cns treatment) for at least 2 weeks prior to enrollment. in addition, patients must have stopped taking corticosteroids or be taking a stable or decreasing dose of ≤10 mg prednisone daily (or equivalent) * carcinomatous meningitis * active known or suspected autoimmune disease or interstitial lung disease * prior treatment on either arm of study ca209-017 or ca184-104 * prior therapy with anti-programmed death-1 (anti-pd-1), anti-programmed cell death ligand 1 (anti-pd-l1), anti-programmed cell death ligand 2 (anti-pd-l2), anti-cd137, or anti-cytotoxic t lymphocyte-associated antigen 4 (anti-ctla-4) antibody, or any other antibody or drug specifically targeting t-cell costimulation or checkpoint pathways * a condition requiring systemic treatment with corticosteroids or other immunosuppressive medications within 14 days of first dose of study drug
hydrating efficacy and tolerance evaluation of a face cream

Conditions: Dry and Damaged Skin

Summary: aim of the study was to evaluate by non-invasive instrumental evaluations tolerance and hydrating activity of a face topic product, to be applied twice a day, morning and evening, for an uninterrupted period of 8 weeks, by volunteers of both sexes, aged 45-60, who meet the inclusion and exclusion criteria required by the study procedure . it was also aim of this study to evaluate the hydrating activity of a single product application on the skin damaged by repeated stripping corneum (short term evaluation versus untreated control area).


Eligibility criteria:
inclusion criteria: * both sexes, * age 45-60 years, * caucasian subjects, * agreeing to present at each study visit without make-up, * accepting to follow the instructions received by the investigator, * accepting to not change their habits regarding food, physical activity, face cleansing and make- up use, * agreeing not to apply or take any product or use face massages or other means known to improve skin wrinkle and skin qualities during the entire duration of the study, * accepting not to expose their face to strong uv irradiation (uv session, or sun bathes), during the entire duration of the study, * no participation in a similar study currently or during the previous 3 months * accepting to sign the informed consent form. exclusion criteria: * pregnancy (only for female subjects), * lactation (only for female subjects), * sensitivity to the test product or its ingredients (to be assessed by the investigator during the baseline visit), * subjects whose insufficient adhesion to the study protocol is foreseeable. * presence of cutaneous disease on the tested area as lesions, scars, malformations, * recurrent facial/labial herpes, * clinical and significant skin condition on the test area (e.g. active eczema, dermatitis, psoriasis etc.). * endocrine disease, * hepatic disorder, * renal disorder, * cardiac disorder, * pulmonary disease, * cancer, * neurological or psychological disease, * inflammatory/immunosuppressive disease, * drug allergy. * anti-inflammatory drugs, anti-histaminic, topic (application on the face) and systemic corticosteroids, narcotic, antidepressant, immunosuppressive drugs (with the except of hormonal treatment starting more than 1 year ago), * using of drugs or dietary supplements able to influence the test results in the investigator opinion.
feasibility of technology mediated lifestyle intervention for overweight and obese young adults

Conditions: Overweight and Obesity

Summary: rashakaty (fitness for me) study aimed to design a new technologies-based intervention using a website and smart phone applications and to test the feasibility of implementing a lifestyle intervention using these technologies for overweight and obese university students. the intervention was implemented in two universities in the united arab emirates

poor eating habits and sedentary lifestyle are common among young adults and increase risk for chronic diseases in subsequent years of life. rashakaty (fitness for me) study aimed to design a new technologies-based intervention using a website and smart phone applications and to test the feasibility of implementing a lifestyle intervention using these technologies for overweight and obese university students. the study intervention was guided by social cognitive theory. the study involved the development of a website, integrating educational material and mobile applications for monitoring diet and physical activity and a16-week feasibility trial to promote weight loss, improve food choices and increase physical activity levels. the trial consisted of two arms: rashakaty basic (r-basic) and rashakaty enhanced (r-enhanced).

Eligibility criteria:
inclusion criteria: * overweight or obese (bmi ≥25.0 * adults: female * age: 18-35 years * current user of a smart phone * student in one of the two target universities in the united arab emirates * living in or off the university campus exclusion criteria: * past or planned weight loss surgery * pregnant or breastfeeding * lost 7 kg in the past 3 months * following any weight loss program for 3 months or more * taking any steroid or thyroid hormones treatment or any other medication that may affect body weight * enrolled in medical and nutrition programs since one of the program components was nutrition knowledge assessments
preoperative catastrophizing predicts pain outcome after shoulder, knee and hip arthroplasty

Conditions: Osteoarthritis; Chronic Pain; Catastrophization

Summary: psychologic status is associated with poor outcome after joint arthroplasty and perhaps chronic pain. to enhance the therapeutic effect of a psychologic intervention, the specific disorders or pain-related beliefs that contributed to chronic pain should be identified. we therefore determined whether specific psychologic disorders (depression, anxiety disorder) or health-related beliefs (self-efficacy, pain catastrophizing) are associated with chronic pain after joint arthroplasty for osteoarthritis.


Eligibility criteria:
inclusion criteria: * joint arthgroplasty (shoulder, hip ou knee) * osteoarthritis exclusion criteria: * previous surgery in the same joint

Keywords: arthroplasty
clinical trials stage of 'solesensor': a balance-enhancing shoe insert.

Conditions: Sensation Disorder

Summary: our research has shown that pressure sensation from the soles of the feet (plantar mechanoreceptors) plays an important role in controlling several key aspects of balancing reactions, particularly during compensatory stepping . as a result, age-related loss of plantar pressure sensation, which is very common, can lead to impaired control of these reactions. however, we have shown that it is possible to compensate for balance impairments resulting from this loss of sensation by using special footwear insoles to facilitate sensation from the perimeter of the sole. to date, we have demonstrated the feasibility of this approach in laboratory studies, and we have obtained a u.s. patent for the design concept. however, it remains to be determined whether the benefits of the footwear persist over the long term, or whether there is a habituation of the effect. also, we need to determine whether there are any practical problems associated with wearing such footwear, e.g. due to discomfort or irritation of the skin.


Eligibility criteria:
inclusion criteria: * aged 65 to 75 years exclusion criteria: * any neurological or musculoskeletal ailments that affect their balance * any drugs that affect balance
a clinical study to evaluate the safety and efficacy of mesenchymal stem cells in liver cirrhosis

Conditions: Liver Cirrhosis

Summary: cirrhosis is caused by sustained liver damage over several years either by alcohol, viral infection (hepatitis b, c), a toxic substance (for eg. drugs, excess copper or iron in the liver), or by blockage of biliary system such that the liver undergoes progressive scarring that slowly replaces all of normal liver cells.(lc) represents a late stage of progressive hepatic fibrosis characterized by distortion of the hepatic architecture and formation of regenerative nodules. for this condition of disease the liver transplantation is one of the only effective therapies available ,but due to lack of donors, surgical complications, rejection, and high cost are it's serious problems. presently stem cells are used to be a one of the treatment for the same. so our approach is to evaluate the safety and efficacy of mesenchymal stem cell in condition of liver cirrhosis .

in this study, the patients with liver cirrhosis will undergo administration of human mesenchymal stem cell mscs intravenously for these patients.to observe the results liver function will be monitored by serum analysis.the levels of serum alanine aminotransferase (alt), total bilirubin (tb), prothrombin time (pt), prealbumin(pa) and albumin (alb) will be examined at pre-transfusion, and 6th days to 1 years post-transfusion.also the to see improvement evaluation by meld score ,quality of life ,child-pugh score will be done .

Eligibility criteria:
inclusion criteria * 25 -65 ages eligible for study * clinical diagnosis of liver cirrhosis * ability to comprehend the explained protocol and thereafter give an informed consent as well as sign the required informed consent form (icf) for the study. * expecting lifetime is over three years * ready to come all visits exclusion criteria: * history of life threatening allergic or immune-mediated reaction * positive test results for hiv and aids complex ,hcv , hbsag and syphilis * malignancies * sepsis * vital organs failure * pregnant or lactating women * subject who has been transplanted recently * if the investigator or treating physician feels that the subject with any disease or condition would interfere with the trial or the safety of patient

Keywords: stem cell ,liver cirrhosis
efficacy and safety study of esomeprazole vs omeprazole to treat acute non-variceal upper gastrointestinal bleeding

Conditions: Gastrointestinal Hemorrhage

Summary: the purpose of this study is to assess the efficacy and safety of esomeprazole and omeprazole intravenous every 12 hours for 5 days in subjects with acute non-variceal upper gastrointestinal bleeding


Eligibility criteria:
inclusion criteria: * male or female aged 18-65 years. * gi bleeding or with such signs within 48 hours as judged by the investigator as to have non-variceal upper gi bleeding. * one endoscopically confirmed bleeding peptic ulcer or erosive gastritis exclusion criteria: * gi bleeding caused by esophageal varices * mallory weiss syndrome * zollinger-ellison syndrome * suspicion of gastric malignancy at baseline endoscopy * post-billroth-resection * unknown source of gi bleeding · 2.unstable vital signs

Keywords: acute non-variceal upper gastrointestinal bleeding
optimizing mindfulness and acceptance based behavioral treatment for bulimia nervosa and binge eating disorder

Conditions: Bulimia Nervosa; Bulimia; Atypical; Binge-Eating Disorder; Binge-Eating and Purging Type Anorexia Nervosa; Binge Eating

Summary: the current study will use a full factorial design to identify the independent and combined effects of four core mabt components when combined with standard behavioral treatment for bn and bed. the primary aim of the study will be to evaluate the independent efficacy of mindful awareness, distress tolerance, emotion modulation, and values-based decision making on eating pathology (at posttreatment and at 6 and 12-month follow-ups). secondary aims will be (1) to test target engagement of each mabt component, i.e., to confirm that each treatment component impacts both the variable which it targets and self-regulation and that improvements in these are associated with improvements in outcomes and (2) to test the hypotheses that the efficacy of each component is moderated by related baseline deficits in self-regulation (e.g. individuals with worse distress tolerance at baseline are most likely to benefit from conditions that include the distress tolerance component). a final exploratory aim will be to quantify the component interaction effects, which may be partially additive (because components overlap and/or there is diminishing return), fully additive, or synergistic (in that components may partially depend on each other).


Eligibility criteria:
inclusion criteria: 1. have experienced 12 or more loss of control episodes within the previous 3 months 2. have a bmi above 16 3. are located in the us and wiling/able to participate in remote treatment and assessments 4. are able to give consent exclusion criteria: 1. are unable to fluently speak, write and read english 2. have a bmi below 16 3. are receiving treatment for an eating disorder 4. require immediate treatment for medical complications as a result of eating disorder symptoms 5. have a mental handicap, or are experiencing other severe psychopathology that would limit the participants' ability to comply with the demands of the current study (e.g. severe depression with suicidal intent, active psychotic disorder)

Keywords: mindfulness and acceptance based behavioral treatments eating disorders bulimia nervosa binge eating disorder anorexia nervosa binge/purge type binge eating
local infiltration analgesia in major spine surgery with ropivacaine versus placebo

Conditions: Pain, Postoperative

Summary: the purpose of this study is to examine whether local infiltration analgesia (lia) with ropivacaine and adrenaline is effective in the treatment of postoperative pain after major spine surgery.


Eligibility criteria:
inclusion criteria: * patients eligible for major spine surgery * must speak and understand danish * must be able to give oral and written consent exclusion criteria: * alcohol or medicine abuse * treatment with opioids \> 100 mg daily * allergy to local anesthetics * severe obesity

Keywords: local infiltration analgesia postoperative pain ropivacaine
ivw-1001 phase 1/2 in subjects with dry eye disease

Conditions: Dry Eye Disease

Summary: double-masked, dose-response, trial of ivw-1001 in subjects with dry eye disease.

this is a randomized (1:1:1), multicenter, parallel, vehicle-controlled, double-masked study to evaluate the safety, tolerability, and efficacy of ivw-1001 ophthalmic eyelid wipes in subjects with ded. treatments will be ivw-1001 ophthalmic eyelid wipe 0.2% (high dose), ivw 1001 0.1% (low dose), or ivw-1001 ophthalmic eyelid wipe placebo (vehicle). subjects will participate in a 7-day, run-in period followed by a 28-daydosing period.

Eligibility criteria:
inclusion criteria: 1. subjects of any gender at least 18 years of age at the screening visit 2. able to voluntarily provide written informed consent to participate in the study 3. able and willing to comply with all study procedures and restrictions, follow study instructions, and complete required study visits 4. diagnosis of dry eye disease (ded) exclusion criteria: 1. corneal fluorescein staining score of 4 using the nei grading system 2. intraocular pressure ≥23 mmhg 3. history of glaucoma or ocular hypertension in either eye requiring past or current medical or surgical intervention 4. subjects with ocular inflammatory conditions (eg, conjunctivitis, keratitis, severe anterior blepharitis, etc.) not related to ded
otis humira pregnancy registry

Conditions: Crohn's Disease; Rheumatoid Arthritis

Summary: the purpose of the otis autoimmune disease in pregnancy study is to monitor planned and unplanned pregnancies exposed to certain medications, to evaluate the possible teratogenic effect of these medications and to follow live born infants for one year after birth. with respect to fetal outcome, it is important to evaluate the spectrum of outcomes that may be relevant to a medication exposure during pregnancy, and these include both easily recognizable defects that are visible at birth, as well as, more subtle or delayed defects that may not be readily identifiable without special expertise and observation beyond the newborn period.


Eligibility criteria:
inclusion criteria: * currently pregnant

Keywords: autoimmune diseases adalimumab pregnancy birth defects tnf tumor necrosis factor